When it comes to health data access, there’s often a fine line between compliance and controversy. That line became the battleground in the dispute between Epic Systems and Particle Health, a clash that boiled down to a fundamental question: What is “treatment”?
The latest HITECH Report to Congress, released earlier this month, outlines the evolving landscape of health information technology and the continued push toward a more connected, interoperable health care system. With electronic health records (EHRs) now a staple in most clinical settings, the focus has shifted from adoption to enhancing how data is exchanged and used. The report highlights major achievements, persistent challenges, and future priorities in the journey toward seamless health information sharing.
Effective today, the HTI-1 Final Rule introduces a new TEFCA Manner Exception—potentially a safe harbor for HIEs and HINs under the Information Blocking Rule. But those outside TEFCA may find themselves navigating far narrower exceptions with much higher compliance risk.
On May 1, modifications to the Medicare Conditions of Participation (“CoPs”) went into effect, requiring certain electronic event notifications for admissions, discharges and transfers (“ADTs”) to and from hospitals, critical access hospitals and psychiatric hospitals. To provide guidance to hospitals and state surveyors, CMS released several FAQs as well as interpretive guidance last week to be published in the State Operations Manual.
Hospitals are required to make a “reasonable effort” to ensure that notifications are sent to post-acute care services providers and suppliers, and other practitioners and entities, which need such notifications for treatment, care coordination or quality improvement. Under the new CoP, ADT notifications must be sent for all emergency department and inpatient patients where the hospital, critical access hospital or psychiatric hospital maintains an electronic medical record or administrative system.
The new year has much in store for electronic health information exchange compliance! Today’s post provides an overview of anticipated changes to the health information regulatory landscape in 2021, including increased interoperability efforts and telehealth expansion due to the coronavirus pandemic. It is not surprising that many of the topics discussed below are a direct result of the interoperability requirements created by the 21st Century Cures Act (“Cures Act”) enacted in December 2016.
Seasons Greetings to all of our readers! First, we want to wish you and yours a holiday season filled with health, happiness and hope! We also want to thank you all for continuing to make Legal HIE such a popular and highly visited blog! It puts a smile on our face seeing so many of you enjoying our posts and returning to our site often!
As stockings are being hung by chimneys with care, we want to make sure you know that Legal HIE’s stockings are absolutely stuffed to the brim with tremendous tools, sample forms, polices and turn-key solutions that can help your organization stay on top of the most pressing compliance challenges, and ever-changing healthcare regulatory landscape. 2021 promises to be a year with many new and final regulations going into effect, and being released. The Legal HIE compliance library was created specifically for this purpose – to help busy and overwhelmed compliance officers and attorneys keep up with these changes by offering turn-key samples and solutions as a solid starting point.
Last Friday, the Office for Civil Rights (OCR) issued new Guidance on how HIPAA permits covered entities and their business associates to use health information exchanges (HIEs) to disclose PHI for the public health activities of a Public Health Authority (PHA). Specifically, it provides examples relevant to the COVID-19 public health emergency. OCR Director, Roger Severino, specifically notes that the Guidance was issued:
“to highlight how HIPAA supports the use of health information exchanges in sharing health data to improve the public’s health, particularly during the COVID-19 public health emergency.”.
Although much of the Guidance document simply reiterates the controlling HIPAA Privacy Rule provisions and definitions which have always afforded a mechanism through which covered entities (CE) and their contracted business associates (BA) can share ePHI with a public health authority for public health purposes, there are a few notable new take-away nuggets.
The award will allocate $2.5M to fund up to 5 awards (in the amount of up to $500K EACH) with a period of performance of up to 2 years in the form of cooperative agreements with funding contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public. SHORT TURN AROUND! Deadline is September 1, 2020 to get Applications in.
Late last week, HHS published new Guidance that specifies what additional data must be reported by laboratories along with COVID-19 test results. Reporting of certain data elements by laboratories are legally required, while reporting of other identifiable demographic data is encouraged but not mandatory. The Guidance notes that state and local privacy standards apply to the collection of identifiable demographic data. Importantly, HHS expressly supports health information exchanges (HIEs) being leveraged to facilitate required data collection and reporting.
As part of its comprehensive COVID-19 response, Congress quietly passed through changes to the federal drug and alcohol confidentiality framework known as “Part 2” under the CARES Act, enacted on March 27. One of the more underreported components of the CARES Act, the changes do not completely overhaul the Part 2 regulations, however, they relax several restrictions that health care providers have struggled with, particularly in the electronic exchange and electronic health records (“EHR”) context (the “CARES Act Changes”).
On April 2nd, HHS announced a new “Notification of Enforcement Discretion Under HIPAA to Allow Uses and Disclosures of PHI by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19” (published in 85 Fed. Reg 193292 (April 7, 2020)). Government officials...
SAMHSA Public Session to Discuss Part 2 Regulations & HIE The Part 2 regulations which govern and protect information created by drug and alcohol rehabilitation providers have caused challenges for electronic health information exchange ever since HIE became a household term (….ok, well at...
ONC Sells Successes of Health IT Adoption to Congress in Annual Report The ONC released its second annual report on the adoption of health IT this past June. The report provides a snapshot of the nation’s efforts and continuing barriers to health IT adoption. Although EHRs have...
ONC Releases Governance Framework for Trusted HIE After backtracking on developing “Rules of the Road” for trusted electronic health information exchange (HIE) last year, ONC has released its promised Governance Framework for HIE after months of collaboration with stakeholders. Crafted...
HHS Releases RFI on Interoperability and HIE HHS, CMS and ONC have released a Request for Information (RFI) seeking input on policies and programs to encourage health information exchange (HIE) through interoperable systems. Although the Medicare and Medicaid EHR Incentive Programs and...